Applications are invited from suitably qualified candidates for a fixed-term contract position as a Clinical Research Data Manager within the HRB Clinical Research Facility at the National University of Ireland, Galway (CRFG). The position is available immediately for a period of one year, with potential to extend subject to project success and funding acquisition.
The CRFG provides an integrated Data Management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology. The post holder will provide professional management and co-ordination of clinical research data as well as implementing the latest research-based data management processes as determined by national and international clinical research management bodies. The role will involve Case Report Form (CRF) development or amendment, data collection, review and discrepancy management to ensure data quality and consistency. The post holder will contribute to the generation of complex data management solutions resulting in the development of customised research study databases in accordance with the study protocol and regulatory processes.
A variety of profiles will be considered for this post, for example a nurse with IT skills and research experience, a person with an IT background with data management experience or a data manager with IT skills.
Please see www.crfg.ie for more information on the facility.
The postholder will require a thorough understanding of the entire clinical research process to anticipate and fulfil the data needs of each study. This will involve working closely with the other members of the team including Principal Investigators to devise the data requirements based upon a clinical trial protocol and manage the creation of Case Report Forms. The role will involve CRF design and development (both paper and electronic), data collection, review and discrepancy management to ensure data quality and consistency, in accordance with ICH GCP standards.
The successful candidate will contribute to the research and data management functions within the Data Management team, working with clinical staff and CRFG management to establish workloads, timelines and priorities.
Electronic Data Capture of clinical research data in the HRB-CRFG is an essential component of our clinical research activities, managed through a variety of electronic programs. It is the responsibility of the Clinical Research Data Manager to plan for and resolve any issues that may occur during the capture of data in electronic format as well as ensuring that the data is high quality and delivered for analysis in an accurate and efficient fashion. The post holder will be expected to support funding submissions process by providing advice on Data Management aspects.
- Contribute to the design/review of the study protocol and provide input to the clinical trial team on data management issues.
- Design case report forms and ensure effective management of their generation and quality control.
- Prepare Case Report Form (CRF) completion instructions and present material for clinical trial activities at investigator meetings and site initiation visits.
- Train site personnel to help improve the quality of the data being collected.
- Assist with the development of training programs for Principal Investigators and research staff in data management.
- Define database requirements and data validations.
- Develop reports to track accrual and measure data quality.
- Prepare clinical trial documentation including the data management plan.
Generate accurate data clarification requests and track all queries through their resolution and filing in the CRF.
Update tracking systems and create/maintain trial master files (TMF) and appropriate study documentation.
Ensure compliance with all ICH-GCP/EU/IRL regulations governing clinical trials.
Assist in standardising data management procedures and data definitions within the department.
- Review, analyse, and validate clinical research data to ensure consistency, integrity and accuracy based on project specific guidelines in preparation for abstract submissions/publications
Support CRFG research funding submission process by providing advice on Clinical Research Data Management aspects.
- Encode all clinical data in agreement with PI and statistician.
- Ensure appropriate and timely communications with investigative sites in the collection, entry, management, quality control and analysis of data, as required by investigators and sponsors.
- Ensure that Standard Operating Procedures (SOPs) are followed.
- Participate in system and vendor validations as required by the Senior Data Manager
- Participate in audit as required within the department
- Undertake additional data activities as assigned by a Senior Data Manager
- University degree or equivalent professional experience (minimum 5 years)
- Minimum 2 years relevant work experience in a clinical research data management related role.
- Evidence of knowledge of clinical research, associated processes and regulations
- Strong communication skills
- Effective organizational skills and detail orientated.
- A high degree of motivation and ability to use initiative
- An ability to work within a team
- proven ability to demonstrate a good and confident command of spoken & written English, sufficient to successfully discuss and explain complex technical ideas in simple & concise terms to a diverse range of stakeholders
- An IT qualification (Knowledge of SQL, Java, Python or similar would be useful but not essential)
- Nursing qualification or Life science qualification
- Nursing experience
- ICH-GCP Training
Salary: €37,874 – €43,783 per annum.
Start date: Position is available immediately.
NB: Gárda clearance is a requirement for this post
Continuing Professional Development/Training:
Researchers at NUI Galway are encouraged to avail of a range of training and development opportunities designed to support their personal career development plans.
Further information on research and working at NUI Galway is available on Research at NUI Galway
For information on moving to Ireland please see www.euraxess.ie
Further information about our centre is available at www.crfg.ie
Applications to include a covering letter, CV,and the contact details of three referees should be sent, via e-mail (in word or PDF only) to firstname.lastname@example.org
Please put reference number NUIG 004-20 in subject line of e-mail application.
Closing date for receipt of applications is 5.00 pm Friday 31st January 2020.
A panel may be formed for future similar posts.
All positions are recruited in line with Open, Transparent, Merit (OTM) and Competency based recruitment
National University of Ireland, Galway is an equal opportunities employer.